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UK/MOV/0117/0150(2)
Date of prep: September 2018

prescribing
information

REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)
BEFORE PRESCRIBING

Presentation:
Movicol
Sachet of white powder which dissolves in about 125ml of water to make a lemon/lime flavoured drink. Each sachet contains: 13.1250g macrogol 3350, 0.1785g sodium hydrogen carbonate, 0.3507g sodium chloride and 0.0466g potassium chloride.

Movicol Plain
Sachet of white powder which dissolves in about 125ml of water. Each sachet contains: 13.1250g macrogol 3350, 0.1786g sodium hydrogen carbonate, 0.3508g sodium chloride and 0.0502g potassium chloride. Does not contain flavourings or sweeteners.

Movicol Chocolate
Sachet of white to light brown powder which dissolves in about 125ml of water to make a chocolate flavoured drink. Each sachet contains: 13.1250g macrogol 3350, 0.1785g sodium hydrogen carbonate, 0.3507g sodium chloride and 0.0317g potassium chloride.

Movicol Liquid
A clear concentrated liquid, which is diluted in water to make an orange flavoured drink. Each 25 ml of Movicol Liquid is diluted in 100ml of water before use and contains the following active ingredients: 13.1250g macrogol 3350, 0.1785g sodium hydrogen carbonate, 0.3507g sodium chloride and 0.0466g potassium chloride.

Movicol Ready to Take
A clear, colourless to light yellow, oral solution in sachet. Each 25 ml sachet contains: 13.1250g macrogol 3350, 0.1786g sodium hydrogen carbonate, 0.3508g sodium chloride and 0.0502g potassium chloride.

Movicol-Half
Sachet of white powder which dissolves in about 62.5ml of water to make a lemon and lime flavoured drink. Each sachet contains: 6.5630g macrogol 3350, 0.0893g sodium hydrogen carbonate, 0.1754g sodium chloride and 0.0233g potassium chloride.

Movicol Paediatric Plain
Sachet of white powder, which dissolves in about 62.5 ml of water. Each sachet contains: 6.5630g macrogol 3350, 0.0893g sodium hydrogen carbonate, 0.1754g sodium chloride and 0.0251g potassium chloride. Does not contain flavourings or sweeteners.

Movicol Paediatric Chocolate
Sachet of white to light brown powder, which dissolves in about 62.5ml of water to make a chocolate flavoured drink. Each sachet contains: 6.5630g macrogol 3350, 0.0893g sodium hydrogen carbonate, 0.1754g sodium chloride and 0.0159g potassium chloride.

Uses:
Movicol, Movicol Plain, Movicol Ready to Take, Movicol Chocolate and Movicol-Half: Treatment of chronic constipation and faecal impaction in adults, adolescents (aged 12 years or older) and older people.
Movicol Liquid: Treatment of chronic constipation.
Movicol Paediatric Plain and Movicol Paediatric Chocolate: Treatment of chronic constipation in children aged 2-11 years. For the treatment of faecal impaction in children from the age of 5 years.

Dosage and administration:

Movicol
Movicol Plain
Movicol Chocolate

Dose = 1 sachet dissolved in 125 ml water

Movicol Ready to Take
Dose = 1 sachet which is ready to take.

 

Chronic Constipation: 1-3 doses per day according to individual response. For extended use, adjust dose down to 1 or 2 doses*.

Faecal Impaction: 8 doses per day. A course of treatment does not normally exceed 3 days. The 8 doses should be taken over 6 hours (2 doses per hour maximum in cardiovascular impairment). The 8 doses may be dissolved in 1 litre of water.
It is recommended that patients using Movicol Ready to Take for faecal impaction take an additional 1 litre of fluid per day.

Movicol Liquid
Dose = 25 ml diluted with 100 ml water

 

Chronic Constipation: 1-3 doses per day according to individual response. For extended use, adjust dose down to 1 or 2 doses*.

Faecal Impaction: Not recommended.

 

Movicol-Half
Dose = 1 sachet dissolved in 62.5 ml water

 

Chronic Constipation: 2-6 doses per day according to individual response. For extended use, adjust dose down to 2 or 4 doses*.

Faecal Impaction: 16 doses per day. A course of treatment does not normally exceed 3 days. The 16 doses should be taken over 6 hours (4 doses per hour maximum in cardiovascular impairment). The 16 doses may be dissolved in 1 litre of water.

 

*As for all laxatives, prolonged use is not usually recommended. Extended use may be necessary in patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in particular opioids and antimuscarinics. A course of treatment does not normally exceed 2 weeks, but can be repeated if required.

Movicol Paediatric Plain
Movicol Paediatric Chocolate

Dose = 1 sachet dissolved in 62.5 ml of water

Chronic Constipation: The usual starting dose is 1 sachet daily for children aged 2-6 years, and 2 sachets daily for children aged 7-11 years. The dose should be adjusted up or down as required to produce regular soft stools. If the dose needs increasing this is best done every second day. The maximum dose needed does not normally exceed 4 sachets a day. Treatment of children with chronic constipation needs to be for a prolonged period (at least 6-12 months). However the safety and efficacy has only been proven for a period of up to three months. Treatment should be stopped gradually and resumed if constipation resumes.

Faecal Impaction: Escalating dose regimen starting with 4 sachets a day up to 12 sachets a day (at day 7) for children aged 5-11 years. Refer to Summary of Product Characteristics (SmPC) for full dosing recommendations. Not recommended in children with cardiovascular impairment or renal insufficiency. Doses for prevention of re-impaction should be as for patients with chronic constipation.

Contraindications:
Intestinal perforation or obstruction due to structural or functional disorders of the gut wall, ileus and severe inflammatory conditions of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic megacolon. Hypersensitivity to macrogol, or any of the excipients.

Warnings and precautions for use:
The fluid content of the re-constituted solution does not replace regular fluid intake and adequate fluid intake must be maintained.

Diagnosis of impaction should be confirmed. If patients develop any symptoms indicating shifts of fluids/electrolytes the product should be stopped immediately.

When using paediatric forms of Movicol to treat faecal impaction, use with caution in patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness.

Movicol Liquid contains 45.6mg of benzyl alcohol in each 25ml dose. Movicol Chocolate contains 14.1 mg of benzyl alcohol per sachet and Movicol Paediatric Chocolate contains 7.0 mg benzyl alcohol per sachet. Do not exceed the maximum recommended daily dose of Movicol Liquid. Benzyl alcohol may cause anaphylactoid reactions.

Interactions:
There is a possibility that the absorption of concomitantly administered medication could be transiently reduced.

Pregnancy and lactation:
Can be used during pregnancy and lactation.

Undesirable effects:
Reactions related to the gastrointestinal tract are the most common and include: abdominal pain, abdominal distension, nausea, vomiting, dyspepsia, diarrhoea, flatulence, borborygmi and anal discomfort. Allergic reactions, including anaphylactic reactions, dyspnoea and skin reactions (e.g. angioedema, urticarial, pruritus, rash and erythema) can occur. Other effects can include electrolyte disturbances, headache and peripheral oedema.

Licensing and legal category:
Movicol
Legal category: P. Cost: 20 sachets £5.41, 30 sachets £8.11, 50 sachets £13.49.
MA number: PL 00322/0070.

Movicol Plain
Legal Category: P. Cost: 30 sachets £8.11, 50 sachets £13.49. MA number: PL 20142/0004.

Movicol Chocolate
Legal Category: P. Cost: 30 sachets £8.11. MA number: PL 00322/0086.

Movicol Liquid
Legal Category: P. Cost: 500ml UK £5.41. MA number : PL 20011/0007.

Movicol Ready to Take
Legal Category: P. Cost 10 sachets £2.57, 30 sachets £7.72. MA number PL20142/0019.

Movicol-Half
Legal Category: P. Cost: 20 sachets £3.54, 30 sachets £5.31. MA number: PL 00322/0080.

Movicol Paediatric Plain
Legal Category: POM; Cost: 30 sachets £4.38; MA number: PL 20011/0005.

Movicol Paediatric Chocolate
Legal Category: POM; Cost: 30 sachets £4.38; MA number: PL 20011/0004.

For further information contact:

Norgine Pharmaceuticals Limited
Norgine House
Moorhall Road
Harefield
Uxbridge
UB9 6NS
01895 826606
E-mail: medinfo@norgine.com

Date of preparation: March 2018

Version number: UK/MOV/0318/0199

Adverse events should be reported. Reporting forms and information
can be found at www.mhra.gov.uk/yellowcard. Adverse events should
also be reported to Medical Information at Norgine Pharmaceuticals
Ltd on 01895 826606.

 

 

 

macrogol 3350, sodium hydrogen carbonate,
sodium chloride, potassium chloride
macrogol 3350, sodium hydrogen carbonate,
sodium chloride, potassium chloride
macrogol 3350, sodium hydrogen carbonate,
sodium chloride, potassium chloride
UK/MOV/0117/0150(2)
Date of prep: September 2018

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